EP2900310A1 - Multi-angulated catheter - Google Patents

Multi-angulated catheter

Info

Publication number
EP2900310A1
EP2900310A1 EP13840954.5A EP13840954A EP2900310A1 EP 2900310 A1 EP2900310 A1 EP 2900310A1 EP 13840954 A EP13840954 A EP 13840954A EP 2900310 A1 EP2900310 A1 EP 2900310A1
Authority
EP
European Patent Office
Prior art keywords
angulated
shaft
catheter
angulated catheter
straight portion
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP13840954.5A
Other languages
German (de)
French (fr)
Other versions
EP2900310A4 (en
EP2900310B1 (en
Inventor
Mladen I. VIDOVICH
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
University of Illinois System
Government of the United States of America
Original Assignee
US Department of Veterans Affairs
University of Illinois at Urbana Champaign
University of Illinois System
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US13/722,511 external-priority patent/US10463781B2/en
Application filed by US Department of Veterans Affairs, University of Illinois at Urbana Champaign, University of Illinois System filed Critical US Department of Veterans Affairs
Publication of EP2900310A1 publication Critical patent/EP2900310A1/en
Publication of EP2900310A4 publication Critical patent/EP2900310A4/en
Application granted granted Critical
Publication of EP2900310B1 publication Critical patent/EP2900310B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0041—Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/005—Devices for introducing or retaining media, e.g. remedies, in cavities of the body for contrast media
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • A61M2025/0046—Coatings for improving slidability
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0102—Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod

Definitions

  • This invention relates generally to coronary catheters. More particularly, this invention relates to an improved, preshaped catheter for use in cardiac ventriculography.
  • Cardiac ventriculography is the radiographic examination of a ventricle of the heart that involves injection of an x-ray contrast agent, usually iodinated contrast dye, into the heart's ventricle(s), typically the left ventricle.
  • an x-ray contrast agent usually iodinated contrast dye
  • This iodinated contrast material can be traced through the heart using special cameras or scanners thereby enabling studies of the pumping function of the heart.
  • the left ventricle may be a particularly difficult chamber of the heart to obtain x-ray imaging.
  • so-called pigtail catheters are used, being threaded retrogradely through the aorta, around the aortic arch, and through the aortic valve until the distal tip of the catheter resides in the ventricle.
  • an x-ray machine such as a fluoroscope
  • a bolus of x-ray contrast fluid is injected through the catheter at a high pressure (500-900 psi) into the ventricle, to quickly fill the ventricle with x-ray contrast media.
  • a high pressure 500-900 psi
  • Pigtail catheters used in cardiac ventriculography are produced by numerous medical supply companies and are available in a range of lengths and sizes to meet different needs.
  • pigtail catheters are designed as either "straight" with no angle or “angled” with angulations of 145 and 155 degrees.
  • the angle of the aorta is not favorable for these catheters and they may be more difficult to insert into the left ventricle compared to the femoral approach.
  • a catheter that is so dimensioned as to facilitate accessing the left ventricle from an arm of a patient.
  • this invention is a multi-angulated catheter comprising, in order: (a) a coiled end; (b) a first straight portion having a straight portion length, (c) a first shaft connected to said first straight portion at a first obtuse angle, wherein said first shaft has a first shaft length, said first shaft including a distal end connected to said first straight portion and a proximal end opposite said distal end, and (d) a second shaft connected to said first shaft on said proximal end, said first shaft extending from said second shaft at a second obtuse angle, one of said first and second obtuse angles being a positive angle and the other being a negative angle.
  • the multi-angulated catheter is flexible so as to afford being straightened when it is advanced over a guide wire.
  • the multi-angulated catheter returns to a multi-angulated position after the guide wire is withdrawn.
  • the first straight portion length, the first shaft length, and the first and second obtuse angles are so dimensioned as to facilitate accessing a left ventricle from an arm of a patient.
  • this invention is a multi-angulated catheter comprising in order: (a) a coiled end; (b) a first straight portion having a first straight portion length; (c) a first shaft including a distal end connected to said first straight portion and a proximal end opposite said distal end, said first shaft having a first shaft length; and (d) a second shaft connected to said first shaft on said proximal end.
  • the multi-angulated catheter is flexible so as to afford being straightened when it is advanced over a guide wire. The multi-angulated catheter returns to a multi-angulated position after the guide wire is withdrawn.
  • the first shaft and the first straight portion define a first obtuse angle when viewed from a direction substantially perpendicular to a plane defined by the first and second shaft.
  • the first straight portion extends out of plane with respect to a plane defined by the first and second shafts.
  • this invention is a method for radial ventriculography comprising inserting a guide wire into an arm of a patient and inserting a multi-angulated catheter over said guide wire into said arm.
  • the multi-angulated catheter comprises a coiled end, a first straight portion, a first shaft connected to the first straight portion at a first obtuse angle, the first shaft including a distal end connected to the first straight portion and a proximal end opposite the distal end, and a second shaft connected to the first shaft on the proximal end.
  • the multi-angulated catheter is then advanced over the guide wire through an artery into the patient's heart.
  • the multi-angulated catheter is flexible so as to afford being straightened when it is advanced over the guide wire.
  • the guide wire is then withdrawn, whereupon the multi-angulated catheter returns to a multi-angulated position.
  • the multi- angulated catheter is then advanced in the multi-angulated position into a left ventricle of the patient.
  • a radiopaque dye is then injected into the left ventricle, and a visual representation is made of the left ventricle.
  • FIG. 1 Schematic illustration of a conventional catheter.
  • FIG. 2 Schematic illustration of a multi-angulated catheter according to one embodiment of the invention.
  • FIG. 3 Schematic illustration of the multi-angulated catheter of FIG. 2 with slightly different dimensions.
  • FIG. 4 Schematic illustration of a multi-angulated catheter according to an alternate embodiment of the invention.
  • the multi-angulated catheter is so dimensioned as to facilitate accessing the left ventricle from an arm of a patient.
  • the multi- angulated catheter generally includes in order: (a) a coiled end; (b) a first straight portion having a first straight portion length; (c) a first shaft including a distal end connected to the first straight portion and a proximal end opposite the distal end, the first shaft and the first straight portion defining a first obtuse angle, the first shaft having a first shaft length; and (d) a second shaft connected to the first shaft on said proximal end.
  • the catheter is flexible so as to afford being straightened when it is advanced over a guide wire.
  • the catheter resiliently returns to a multi-angulated position after the guide wire is withdrawn.
  • radial ventriculography refers to cardiac procedure wherein a catheter is threaded through an arm of a patient rather than the larger femoral artery in the groin.
  • the catheter may be threaded through the small radial artery in the wrist, the ulnar artery in the wrist, the brachial artery in the elbow, or any other peripheral arteries in the arm of a patient.
  • the catheter is then advanced to the left ventricle of the patient and a radiopaque dye is then injected into the left ventricle.
  • a visual representation is then made of the left ventricle.
  • FIG. 1 shows a conventional catheter comprising in order: (a) a coiled end 1; (b) a first straight portion 2 having a length of about 15 to about 40 mm; (c) a first bend 3; and (d) a shaft 4, in which the first straight portion 2, the first bend 3 and the shaft 4 define an angle of about 105° to about 140°.
  • the coiled end 1 of the catheter defines a spiral "pigtail.”
  • the tip of the pigtail comprises an open aperture and the pigtail may also contain one or more apertures to aid in uniform filling the ventricle with x-ray contrast fluid.
  • Pigtail catheters are known in the art. See, for example US Patent No. 5,307,403, incorporated herein by reference.
  • the catheter can be produced in any of the standard French sizes (4, 5, 6, 7 or 8 French).
  • FIGS. 2 and 3 show a multi-angulated catheter 10 according to one embodiment of the invention, comprising, in order: (a) a coiled end 1; (b) a first straight portion 2 having a straight portion length L 2 , (c) a first shaft 14 connected to said first straight portion 2 at a first obtuse angle ⁇ ⁇ 5 wherein said first shaft 14 has a first shaft length L 14 , the first shaft 14 including a distal end 18 connected to the first straight portion 2 and a proximal end 22 opposite said distal end 18, and (d) a second shaft 26 connected to the first shaft 14 on the proximal end 22.
  • the first shaft 14 extends from the second shaft 26 at a second obtuse angle ⁇ 2 .
  • the first obtuse angle ⁇ is a positive angle, i.e., defined by a counterclockwise rotation when viewed from above
  • the second obtuse angle ⁇ 2 is a negative angle, i.e., defined by a clockwise rotation when viewed from above.
  • the first obtuse angle ⁇ is a negative angle
  • the second obtuse angle ⁇ 2 is a positive angle.
  • the first straight portion length L 2 is so dimensioned as to facilitate accessing a left ventricle from an arm of a patient.
  • the first straight portion length L 2 is about 15 mm to about 40 mm.
  • FIG. 2 illustrates the first straight portion length L 2 as 40 mm
  • FIG. 3 illustrates the first straight portion length L 2 as 15 mm.
  • the first straight portion length is about 15 mm or more, about 16 mm or more, about 17 mm or more, about 18 mm or more, about 19 mm or more, about 20 mm or more, about 21 mm or more, about 22 mm or more, about 23 mm or more, about 24 mm or more, about 25 mm or more, about 26 mm or more, about 27 mm or more, about 28 mm or more, about 29 mm or more, about 30 mm or more, about 31 mm or more, about 32 mm or more, about 33 mm or more, about 34 mm or more, about 35 mm or more, about 36 mm or more, about 37 mm or more, about 38 mm or more, or about 39 mm or more.
  • the first straight portion length L 2 is about 40 mm or less, about 39 mm or less, about 38 mm or less, about 37 mm or less, about 36 mm or less, about 35 mm or less, about 34 mm or less, about 33 mm or less, about 32 mm or less, about 31 mm or less, about 30 mm or less, about 29 mm or less, about 28 mm or less, about 27 mm or less, about 26 mm or less, about 25 mm or less, about 24 mm or less, about 23 mm or less, about 22 mm or less, about 21 mm or less, about 20 mm or less, about 19 mm or less, about 18 mm or less, about 17 mm or less, or about 16 mm or less.
  • the first shaft length L 14 is so dimensioned as to facilitate accessing a left ventricle from an arm of a patient.
  • the first shaft length L 14 is about 20 mm to about 40 mm.
  • FIG. 2 illustrates the first shaft length L 14 as 20 mm
  • FIG. 3 illustrates the first shaft length L 14 as 30 mm.
  • the first shaft length L 14 is about 20 mm or more, about 21 mm or more, about 22 mm or more, about 23 mm or more, about 24 mm or more, about 25 mm or more, about 26 mm or more, about 27 mm or more, about 28 mm or more, about 29 mm or more, about 30 mm or more, about 31 mm or more, about 32 mm or more, about 33 mm or more, about 34 mm or more, about 35 mm or more, about 36 mm or more, about 37 mm or more, about 38 mm or more, or about 39 mm or more.
  • the first shaft length L 14 is about 40 mm or less, about 39 mm or less, about 38 mm or less, about 37 mm or less, about 36 mm or less, about 35 mm or less, about 34 mm or less, about 33 mm or less, about 32 mm or less, about 31 mm or less, about 30 mm or less, about 29 mm or less, about 28 mm or less, about 27 mm or less, about 26 mm or less, about 25 mm or less, about 24 mm or less, about 23 mm or less, about 22 mm or less, or about 21 mm or less.
  • the second shaft 26 has a second shaft length, and the second shaft length is greater than said first shaft length L 14 .
  • the first and second obtuse angles ⁇ , ⁇ 2 are so dimensioned as to facilitate accessing a left ventricle from an arm of a patient.
  • the first obtuse angle ⁇ is about 140°. In other embodiments, however, the first obtuse angle ⁇ may be about 105° to about 140°. In further embodiments, the first obtuse angle ⁇ is about 105° or more, about 110° or more, about 115° or more, about 120° or more, about 125° or more, about 130° or more, or about 135° or more.
  • the first obtuse angle ⁇ is about 140° or less, about 135° or less, about 130° or less, about 125° or less, about 120° or less, about 115° or less, or about 110° or less.
  • the second obtuse angle ⁇ 2 is about 135° to about 150°.
  • FIG. 2 illustrates the second obtuse angle ⁇ 2 as 150°
  • FIG. 3 illustrates the second obtuse angle ⁇ 2 as 135°.
  • the second obtuse angle ⁇ 2 is about 135° or more, about 140° or more, or about 145° or more.
  • the second obtuse angle ⁇ 2 is about 150° or less, about 145° or less, or about 140° or less.
  • the proximal end 22 is positioned from the coiled end 1 at a distance of about 30 mm to about 60 mm. In some embodiments, the proximal end 22 is positioned from the coiled end 1 at a distance of about 30 mm or more, about 35 mm or more, about 40 mm or more, about 45 mm or more, about 50 mm or more, or about 55 mm or more. In further embodiments, the proximal end 22 is positioned from the coiled end 1 at a distance of about 60 mm or less, about 55 mm or less, about 50 mm or less, about 45 mm or less, about 40 mm or less, or about 35 mm or less.
  • the multi-angulated catheter 10 is flexible so as to afford being straightened when it is advanced over a guide wire.
  • the multi-angulated catheter 10 resiliently returns to a multi-angulated position after the guide wire is withdrawn.
  • the catheter according to this invention may be made of any physiologically-compatible material having sufficient pliability and elasticity to permit bending of the catheter with no resultant permanent deformation. Such materials are known in the art and include, for example plastics such as polyurethane.
  • the catheter may further comprise, on its surface or a portion thereof a friction reducing agent which may be a hydrophilic polymer.
  • the catheter when wetted, as takes places in the insertion of the catheter into the aorta, provide an improved slippery surface to the catheter, which greatly assists in its placement prior to applying aliquots of x-ray contrast media to the heart.
  • the catheter optionally comprises an inner lining of resin polymer that may be braided. The inner lining may help provide a suitable stiffness to the catheter.
  • FIG. 4 shows a multi-angulated catheter according to an alternate embodiment of the invention.
  • the multi-angulated catheter 100 in this embodiment comprises in order: (a) a coiled end 1; (b) a first straight portion 104 having a first straight portion length; (c) a first shaft 14 including a distal end 18 connected to the first straight portion 104 and a proximal end 22 opposite the distal end 18, the first shaft 14 having a first shaft length L 14 ; and (d) a second shaft 26 connected to the first shaft 14 on the proximal end 22.
  • the multi-angulated catheter 100 is flexible so as to afford being straightened when it is advanced over a guide wire.
  • the multi-angulated catheter 100 resiliently returns to a multi-angulated position after the guide wire is withdrawn.
  • the first shaft 14 and the first straight portion 104 define a first obtuse angle ⁇ when viewed from a direction substantially perpendicular to a plane defined by the first and second shafts 14, 26.
  • the first straight portion 104 extends out of plane with respect to the plane defined by the first and second shafts 14, 26.
  • the first straight portion 104 extends from the plane defined by the first and second shafts 14, 26 at an angle of about 5° to about 140°. In some embodiments, the first straight portion 104 extends from the plane defined by the first and second shafts 14, 26 at an angle of about 5° or more, about 10° or more, about 15° or more, about 20° or more, about 25° or more, about 30° or more, about 35° or more, about 40° or more, about 45° or more, about 50° or more, about 55° or more, about 60° or more, about 65° or more, about 70° or more, about 75° or more, about 80° or more, about 85° or more, about 90° or more, about 95° or more, about 100° or more, about 105° or more, about 110° or more, about 115° or more, about 120° or more, about 125° or more, about 130° or more, or about 135° or more.
  • the first straight portion 104 extends from the plane defined by the first and second shafts 14, 26 at an angle of about 140° or less, about 135° or less, about 130° or less, about 125° or less, about 120° or less, about 115° or less, about 110° or less, about 105° or less, about 100° or less, about 95° or less, about 90° or less, about 85° or less, about 80° or less, about 75° or less, about 70° or less, about 65° or less, about 60° or less, about 55° or less, about 50° or less, about 45° or less, about 40° or less, about 35° or less, about 30° or less, about 25° or less, about 20° or less, about 15° or less, or about 10° or less.
  • the first straight portion 104 in this embodiment creates a three-dimensional profile for the multi-angulated catheter 100.
  • the three-dimensional profile of the multi-angulated catheter 100 can facilitate accessing a left ventricle from an arm of a patient
  • the present disclosure is also directed to a method of using the multi-angulated catheter.
  • a physician inserts a guide wire into an arm of a patient.
  • the guide wire may be a conventional J-tip wire with a diameter of 0.89 mm or 0.97 mm.
  • the multi-angulated catheter 10, 100 is then inserted over the guide wire into the arm and advanced over the guide wire through an artery into the patient's heart.
  • the multi-angulated catheter 10, 100 is flexible so as to afford being straightened when it is advanced over the guide wire.
  • the multi-angulated catheter 10, 100 is advanced through the axillary artery, the subclavian artery, the innominate artery, and the ascending aorta. The guide wire is then withdrawn, whereupon the multi-angulated catheter 10, 100 resiliently returns to a multi-angulated position.
  • the multi-angulated catheter 10, 100 is then advanced in the multi-angulated position into a left ventricle of the patient.
  • the multi-angulated catheter is advanced in a clockwise fashion into the left coronary cusp, which may cause the multi-angulated catheter 10, 100 to curl upwards.
  • the multi- angulated catheter 10, 100 may be withdrawn slightly and rotated slightly counterclockwise, so as to allow it to prolapse in the left ventricular cavity.
  • a radiopaque dye is then injected into the left ventricle, and a visual representation is made of the left ventricle.
  • the position of the multi- angulated catheter 10, 100 may be adjusted before or during the dye injection and visual representation.
  • the position of the multi-angulated catheter 10, 100 may be adjusted with slight advancements such as forward and backward, and/or clockwise and counterclockwise, to find a central ventricular position. Such adjustments may help avoiding myocardial staining and ventricular ectopy, and may also help achieving full cavity opacification.
  • pressure measurements may be obtained when the multi-angulated catheter 10, 100 is positioned in the aorta or in the ventricle.
  • the multi-angulated catheter 10, 100 is withdrawn into the ascending aorta.
  • the guide wire is then inserted to straighten the multi- angulated catheter 10, 100, and the catheter 10, 100 is then removed from the patient over the guide wire.

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  • Life Sciences & Earth Sciences (AREA)
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  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Veterinary Medicine (AREA)
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  • Pulmonology (AREA)
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Abstract

The present invention is directed to a multi-angulated catheter and methods of using the multi-angulated catheter. The multi-angulated catheter is so dimensioned as to facilitate accessing the left ventricle from an arm of a patient. The multi-angulated catheter generally includes in order: (a) a coiled end; (b) a first straight portion having a first straight portion length; (c) a first shaft including a distal end connected to the first straight portion and a proximal end opposite the distal end, the first shaft and the first straight portion defining a first obtuse angle, the first shaft having a first shaft length; and (d) a second shaft connected to the first shaft on the proximal end. The catheter is flexible so as to afford being straightened when it is advanced over a guide wire. The catheter resiliently returns to a multi-angulated position after the guide wire is withdrawn.

Description

MULTI-ANGULATED CATHETER
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent Application No. 61/705,183, filed Sept. 25, 2012 and U.S. Utility Patent Application No. 13/722,511, filed Dec. 20, 2012, the content of each of which is incorporated herein by reference in its entirety.
FIELD OF THE INVENTION
[0002] This invention relates generally to coronary catheters. More particularly, this invention relates to an improved, preshaped catheter for use in cardiac ventriculography.
BACKGROUND OF THE INVENTION
[0003] Cardiac ventriculography is the radiographic examination of a ventricle of the heart that involves injection of an x-ray contrast agent, usually iodinated contrast dye, into the heart's ventricle(s), typically the left ventricle. This iodinated contrast material can be traced through the heart using special cameras or scanners thereby enabling studies of the pumping function of the heart.
[0004] However, the left ventricle may be a particularly difficult chamber of the heart to obtain x-ray imaging. Presently, so-called pigtail catheters are used, being threaded retrogradely through the aorta, around the aortic arch, and through the aortic valve until the distal tip of the catheter resides in the ventricle. Then, with the patient under an x-ray machine such as a fluoroscope, a bolus of x-ray contrast fluid is injected through the catheter at a high pressure (500-900 psi) into the ventricle, to quickly fill the ventricle with x-ray contrast media. For a moment, details of the heart structure and action become visible by x- ray imaging, until the contrast media is pumped out of the ventricle.
[0005] Pigtail catheters used in cardiac ventriculography are produced by numerous medical supply companies and are available in a range of lengths and sizes to meet different needs. Currently pigtail catheters are designed as either "straight" with no angle or "angled" with angulations of 145 and 155 degrees. However, with the radial approach the angle of the aorta is not favorable for these catheters and they may be more difficult to insert into the left ventricle compared to the femoral approach. Thus, there has developed a need for a catheter that is so dimensioned as to facilitate accessing the left ventricle from an arm of a patient.
SUMMARY OF THE INVENTION
[0006] The inventor has discovered that a different angulation design, more particularly from about 105 to 140 degrees and introduction of another angle to the catheter at various distances from the tip makes the standard pigtail catheter more suitable for the radial approach.
[0007] Accordingly, in an embodiment, this invention is a multi-angulated catheter comprising, in order: (a) a coiled end; (b) a first straight portion having a straight portion length, (c) a first shaft connected to said first straight portion at a first obtuse angle, wherein said first shaft has a first shaft length, said first shaft including a distal end connected to said first straight portion and a proximal end opposite said distal end, and (d) a second shaft connected to said first shaft on said proximal end, said first shaft extending from said second shaft at a second obtuse angle, one of said first and second obtuse angles being a positive angle and the other being a negative angle. The multi-angulated catheter is flexible so as to afford being straightened when it is advanced over a guide wire. The multi-angulated catheter returns to a multi-angulated position after the guide wire is withdrawn. The first straight portion length, the first shaft length, and the first and second obtuse angles are so dimensioned as to facilitate accessing a left ventricle from an arm of a patient.
[0008] In another embodiment, this invention is a multi-angulated catheter comprising in order: (a) a coiled end; (b) a first straight portion having a first straight portion length; (c) a first shaft including a distal end connected to said first straight portion and a proximal end opposite said distal end, said first shaft having a first shaft length; and (d) a second shaft connected to said first shaft on said proximal end. The multi-angulated catheter is flexible so as to afford being straightened when it is advanced over a guide wire. The multi-angulated catheter returns to a multi-angulated position after the guide wire is withdrawn. The first shaft and the first straight portion define a first obtuse angle when viewed from a direction substantially perpendicular to a plane defined by the first and second shaft. The first straight portion extends out of plane with respect to a plane defined by the first and second shafts.
[0009] In another embodiment, this invention is a method for radial ventriculography comprising inserting a guide wire into an arm of a patient and inserting a multi-angulated catheter over said guide wire into said arm. The multi-angulated catheter comprises a coiled end, a first straight portion, a first shaft connected to the first straight portion at a first obtuse angle, the first shaft including a distal end connected to the first straight portion and a proximal end opposite the distal end, and a second shaft connected to the first shaft on the proximal end. The multi-angulated catheter is then advanced over the guide wire through an artery into the patient's heart. The multi-angulated catheter is flexible so as to afford being straightened when it is advanced over the guide wire. The guide wire is then withdrawn, whereupon the multi-angulated catheter returns to a multi-angulated position. The multi- angulated catheter is then advanced in the multi-angulated position into a left ventricle of the patient. A radiopaque dye is then injected into the left ventricle, and a visual representation is made of the left ventricle.
[0010] Other aspects of the invention will become apparent by consideration of the detailed description and accompanying drawings.
BRIEF DESCRIPTION OF THE FIGURES
[0011] FIG. 1. Schematic illustration of a conventional catheter.
[0012] FIG. 2. Schematic illustration of a multi-angulated catheter according to one embodiment of the invention.
[0013] FIG. 3. Schematic illustration of the multi-angulated catheter of FIG. 2 with slightly different dimensions.
[0014] FIG. 4. Schematic illustration of a multi-angulated catheter according to an alternate embodiment of the invention.
DETAILED DESCRIPTION
[0015] Described herein is a multi-angulated catheter and methods of using the multi- angulated catheter for delivering radiopaque media. The multi-angulated catheter is so dimensioned as to facilitate accessing the left ventricle from an arm of a patient. The multi- angulated catheter generally includes in order: (a) a coiled end; (b) a first straight portion having a first straight portion length; (c) a first shaft including a distal end connected to the first straight portion and a proximal end opposite the distal end, the first shaft and the first straight portion defining a first obtuse angle, the first shaft having a first shaft length; and (d) a second shaft connected to the first shaft on said proximal end. The catheter is flexible so as to afford being straightened when it is advanced over a guide wire. The catheter resiliently returns to a multi-angulated position after the guide wire is withdrawn.
1. Definitions
[0016] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used in the specification and the appended claims, the singular forms "a," "and" and "the" include plural references unless the context clearly dictates otherwise.
[0017] For the recitation of numeric ranges herein, each intervening number there between with the same degree of precision is explicitly contemplated. For example, for the range of 6-9, the numbers 7 and 8 are contemplated in addition to 6 and 9, and for the range 6.0-7.0, the numbers 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, and 7.0 are explicitly contemplated. [0018] As used herein, "radial ventriculography" refers to cardiac procedure wherein a catheter is threaded through an arm of a patient rather than the larger femoral artery in the groin. For example, the catheter may be threaded through the small radial artery in the wrist, the ulnar artery in the wrist, the brachial artery in the elbow, or any other peripheral arteries in the arm of a patient. The catheter is then advanced to the left ventricle of the patient and a radiopaque dye is then injected into the left ventricle. A visual representation is then made of the left ventricle.
2. Multi-Angulated Catheter
[0019] Turning now to the drawings, FIG. 1 shows a conventional catheter comprising in order: (a) a coiled end 1; (b) a first straight portion 2 having a length of about 15 to about 40 mm; (c) a first bend 3; and (d) a shaft 4, in which the first straight portion 2, the first bend 3 and the shaft 4 define an angle of about 105° to about 140°. The coiled end 1 of the catheter defines a spiral "pigtail." The tip of the pigtail comprises an open aperture and the pigtail may also contain one or more apertures to aid in uniform filling the ventricle with x-ray contrast fluid. Pigtail catheters are known in the art. See, for example US Patent No. 5,307,403, incorporated herein by reference. The catheter can be produced in any of the standard French sizes (4, 5, 6, 7 or 8 French).
[0020] FIGS. 2 and 3 show a multi-angulated catheter 10 according to one embodiment of the invention, comprising, in order: (a) a coiled end 1; (b) a first straight portion 2 having a straight portion length L2, (c) a first shaft 14 connected to said first straight portion 2 at a first obtuse angle θΐ5 wherein said first shaft 14 has a first shaft length L14 , the first shaft 14 including a distal end 18 connected to the first straight portion 2 and a proximal end 22 opposite said distal end 18, and (d) a second shaft 26 connected to the first shaft 14 on the proximal end 22. The first shaft 14 extends from the second shaft 26 at a second obtuse angle θ2. In the illustrated embodiment, the first obtuse angle θι is a positive angle, i.e., defined by a counterclockwise rotation when viewed from above, and the second obtuse angle θ2 is a negative angle, i.e., defined by a clockwise rotation when viewed from above. When viewed from below, however, the first obtuse angle θι is a negative angle and the second obtuse angle θ2 is a positive angle.
[0021] In an aspect, the first straight portion length L2 is so dimensioned as to facilitate accessing a left ventricle from an arm of a patient. In some embodiments, the first straight portion length L2 is about 15 mm to about 40 mm. For example, FIG. 2 illustrates the first straight portion length L2 as 40 mm, and FIG. 3 illustrates the first straight portion length L2 as 15 mm. In further embodiments, the first straight portion length is about 15 mm or more, about 16 mm or more, about 17 mm or more, about 18 mm or more, about 19 mm or more, about 20 mm or more, about 21 mm or more, about 22 mm or more, about 23 mm or more, about 24 mm or more, about 25 mm or more, about 26 mm or more, about 27 mm or more, about 28 mm or more, about 29 mm or more, about 30 mm or more, about 31 mm or more, about 32 mm or more, about 33 mm or more, about 34 mm or more, about 35 mm or more, about 36 mm or more, about 37 mm or more, about 38 mm or more, or about 39 mm or more. In further embodiments, the first straight portion length L2 is about 40 mm or less, about 39 mm or less, about 38 mm or less, about 37 mm or less, about 36 mm or less, about 35 mm or less, about 34 mm or less, about 33 mm or less, about 32 mm or less, about 31 mm or less, about 30 mm or less, about 29 mm or less, about 28 mm or less, about 27 mm or less, about 26 mm or less, about 25 mm or less, about 24 mm or less, about 23 mm or less, about 22 mm or less, about 21 mm or less, about 20 mm or less, about 19 mm or less, about 18 mm or less, about 17 mm or less, or about 16 mm or less. This includes a first straight portion length L2 of about 30 mm to about 40 mm.
[0022] In an aspect, the first shaft length L14 is so dimensioned as to facilitate accessing a left ventricle from an arm of a patient. In some embodiments, the first shaft length L14 is about 20 mm to about 40 mm. For example, FIG. 2 illustrates the first shaft length L14 as 20 mm, and FIG. 3 illustrates the first shaft length L14 as 30 mm. In further embodiments, the first shaft length L14 is about 20 mm or more, about 21 mm or more, about 22 mm or more, about 23 mm or more, about 24 mm or more, about 25 mm or more, about 26 mm or more, about 27 mm or more, about 28 mm or more, about 29 mm or more, about 30 mm or more, about 31 mm or more, about 32 mm or more, about 33 mm or more, about 34 mm or more, about 35 mm or more, about 36 mm or more, about 37 mm or more, about 38 mm or more, or about 39 mm or more. In further embodiments, the first shaft length L14 is about 40 mm or less, about 39 mm or less, about 38 mm or less, about 37 mm or less, about 36 mm or less, about 35 mm or less, about 34 mm or less, about 33 mm or less, about 32 mm or less, about 31 mm or less, about 30 mm or less, about 29 mm or less, about 28 mm or less, about 27 mm or less, about 26 mm or less, about 25 mm or less, about 24 mm or less, about 23 mm or less, about 22 mm or less, or about 21 mm or less. The second shaft 26 has a second shaft length, and the second shaft length is greater than said first shaft length L14.
[0023] In an aspect, the first and second obtuse angles θι, θ2 are so dimensioned as to facilitate accessing a left ventricle from an arm of a patient. In the illustrated embodiments, the first obtuse angle θι is about 140°. In other embodiments, however, the first obtuse angle θι may be about 105° to about 140°. In further embodiments, the first obtuse angle θι is about 105° or more, about 110° or more, about 115° or more, about 120° or more, about 125° or more, about 130° or more, or about 135° or more. In further embodiments, the first obtuse angle θι is about 140° or less, about 135° or less, about 130° or less, about 125° or less, about 120° or less, about 115° or less, or about 110° or less. Furthermore, in some embodiments, the second obtuse angle θ2 is about 135° to about 150°. For example, FIG. 2 illustrates the second obtuse angle θ2 as 150°, and FIG. 3 illustrates the second obtuse angle θ2 as 135°. In some embodiments, the second obtuse angle θ2 is about 135° or more, about 140° or more, or about 145° or more. In further embodiments, the second obtuse angle θ2 is about 150° or less, about 145° or less, or about 140° or less.
[0024] In some embodiments, the proximal end 22 is positioned from the coiled end 1 at a distance of about 30 mm to about 60 mm. In some embodiments, the proximal end 22 is positioned from the coiled end 1 at a distance of about 30 mm or more, about 35 mm or more, about 40 mm or more, about 45 mm or more, about 50 mm or more, or about 55 mm or more. In further embodiments, the proximal end 22 is positioned from the coiled end 1 at a distance of about 60 mm or less, about 55 mm or less, about 50 mm or less, about 45 mm or less, about 40 mm or less, or about 35 mm or less.
[0025] The multi-angulated catheter 10 is flexible so as to afford being straightened when it is advanced over a guide wire. The multi-angulated catheter 10 resiliently returns to a multi-angulated position after the guide wire is withdrawn. The catheter according to this invention may be made of any physiologically-compatible material having sufficient pliability and elasticity to permit bending of the catheter with no resultant permanent deformation. Such materials are known in the art and include, for example plastics such as polyurethane. Additionally, the catheter may further comprise, on its surface or a portion thereof a friction reducing agent which may be a hydrophilic polymer. Such agent, when wetted, as takes places in the insertion of the catheter into the aorta, provide an improved slippery surface to the catheter, which greatly assists in its placement prior to applying aliquots of x-ray contrast media to the heart. In further embodiments, the catheter optionally comprises an inner lining of resin polymer that may be braided. The inner lining may help provide a suitable stiffness to the catheter.
[0026] FIG. 4 shows a multi-angulated catheter according to an alternate embodiment of the invention. Like parts are identified using like reference numerals. The multi-angulated catheter 100 in this embodiment comprises in order: (a) a coiled end 1; (b) a first straight portion 104 having a first straight portion length; (c) a first shaft 14 including a distal end 18 connected to the first straight portion 104 and a proximal end 22 opposite the distal end 18, the first shaft 14 having a first shaft length L14; and (d) a second shaft 26 connected to the first shaft 14 on the proximal end 22. The multi-angulated catheter 100 is flexible so as to afford being straightened when it is advanced over a guide wire. The multi-angulated catheter 100 resiliently returns to a multi-angulated position after the guide wire is withdrawn. The first shaft 14 and the first straight portion 104 define a first obtuse angle θι when viewed from a direction substantially perpendicular to a plane defined by the first and second shafts 14, 26. The first straight portion 104 extends out of plane with respect to the plane defined by the first and second shafts 14, 26.
[0027] In some embodiments, the first straight portion 104 extends from the plane defined by the first and second shafts 14, 26 at an angle of about 5° to about 140°. In some embodiments, the first straight portion 104 extends from the plane defined by the first and second shafts 14, 26 at an angle of about 5° or more, about 10° or more, about 15° or more, about 20° or more, about 25° or more, about 30° or more, about 35° or more, about 40° or more, about 45° or more, about 50° or more, about 55° or more, about 60° or more, about 65° or more, about 70° or more, about 75° or more, about 80° or more, about 85° or more, about 90° or more, about 95° or more, about 100° or more, about 105° or more, about 110° or more, about 115° or more, about 120° or more, about 125° or more, about 130° or more, or about 135° or more. In further embodiments, the first straight portion 104 extends from the plane defined by the first and second shafts 14, 26 at an angle of about 140° or less, about 135° or less, about 130° or less, about 125° or less, about 120° or less, about 115° or less, about 110° or less, about 105° or less, about 100° or less, about 95° or less, about 90° or less, about 85° or less, about 80° or less, about 75° or less, about 70° or less, about 65° or less, about 60° or less, about 55° or less, about 50° or less, about 45° or less, about 40° or less, about 35° or less, about 30° or less, about 25° or less, about 20° or less, about 15° or less, or about 10° or less. The first straight portion 104 in this embodiment creates a three-dimensional profile for the multi-angulated catheter 100. The three-dimensional profile of the multi-angulated catheter 100 can facilitate accessing a left ventricle from an arm of a patient.
3. Method of Using the Multi-Angulated Catheter
[0028] The present disclosure is also directed to a method of using the multi-angulated catheter. In an operation such as in a radial ventriculography, a physician inserts a guide wire into an arm of a patient. The guide wire may be a conventional J-tip wire with a diameter of 0.89 mm or 0.97 mm. The multi-angulated catheter 10, 100 is then inserted over the guide wire into the arm and advanced over the guide wire through an artery into the patient's heart. The multi-angulated catheter 10, 100 is flexible so as to afford being straightened when it is advanced over the guide wire. In some embodiments, the multi-angulated catheter 10, 100 is advanced through the axillary artery, the subclavian artery, the innominate artery, and the ascending aorta. The guide wire is then withdrawn, whereupon the multi-angulated catheter 10, 100 resiliently returns to a multi-angulated position.
[0029] The multi-angulated catheter 10, 100 is then advanced in the multi-angulated position into a left ventricle of the patient. In some embodiments, the multi-angulated catheter is advanced in a clockwise fashion into the left coronary cusp, which may cause the multi-angulated catheter 10, 100 to curl upwards. In the upwardly curled position, the multi- angulated catheter 10, 100 may be withdrawn slightly and rotated slightly counterclockwise, so as to allow it to prolapse in the left ventricular cavity.
[0030] A radiopaque dye is then injected into the left ventricle, and a visual representation is made of the left ventricle. In some embodiments, the position of the multi- angulated catheter 10, 100 may be adjusted before or during the dye injection and visual representation. For example, the position of the multi-angulated catheter 10, 100 may be adjusted with slight advancements such as forward and backward, and/or clockwise and counterclockwise, to find a central ventricular position. Such adjustments may help avoiding myocardial staining and ventricular ectopy, and may also help achieving full cavity opacification. In some embodiments, pressure measurements may be obtained when the multi-angulated catheter 10, 100 is positioned in the aorta or in the ventricle.
[0031] After the ventriculography is performed, the multi-angulated catheter 10, 100 is withdrawn into the ascending aorta. The guide wire is then inserted to straighten the multi- angulated catheter 10, 100, and the catheter 10, 100 is then removed from the patient over the guide wire.
[0032] The foregoing has been provided for illustrative purposes only and is not intended to limit the scope of the invention as set forth in the claims.

Claims

CLAIMS What is claimed is:
1. A multi-angulated catheter comprising, in order:
(a) a coiled end;
(b) a first straight portion having a first straight portion length;
(c) a first shaft connected to said first straight portion at a first obtuse angle, wherein said first shaft has a first shaft length, said first shaft including a distal end connected to said first straight portion and a proximal end opposite said distal end, and
(d) a second shaft connected to said first shaft on said proximal end, said first shaft extending from said second shaft at a second obtuse angle, one of said first and second obtuse angles being a positive angle and the other being a negative angle,
wherein said multi-angulated catheter is flexible so as to afford being straightened when it is advanced over a guide wire, said multi-angulated catheter returning to a multi-angulated position after said guide wire is withdrawn, and wherein said first straight portion length, said first shaft length, and said first and second obtuse angles are so dimensioned as to facilitate accessing a left ventricle from an arm of a patient.
2. The multi-angulated catheter of claim 1, wherein said first straight portion length is about 15 mm to about 40 mm.
3. The multi-angulated catheter of claim 1, wherein said first straight portion length is about 30 mm to about 40 mm.
4. The multi-angulated catheter of any one of claims 1-3, wherein said first obtuse angle is about 105° to about 140°.
5. The multi-angulated catheter of any one of claims 1-4, wherein said first shaft length is about 20 mm to about 40 mm.
6. The multi-angulated catheter of any one of claims 1-5, wherein said second obtuse angle is about 135° to about 150°.
7. The multi-angulated catheter of any one of claims 1-6, wherein said proximal end is positioned from said coiled end at a distance of about 30 mm to about 60 mm.
8. The multi-angulated catheter of any one of claims 1-7, wherein said second shaft has a second shaft length, and said second shaft length is greater than said first shaft length.
9. The multi-angulated catheter of any one of claims 1-8, wherein said coiled end comprises an open aperture in a tip of said coiled end.
10. The multi-angulated catheter of any one of claims 1-9, wherein said coiled end comprises one or more apertures in a sidewall of said coiled end.
11. The multi-angulated catheter of any one of claims 1-10, wherein said coiled end comprises a pigtail loop.
12. The multi-angulated catheter of any one of claims 1-11, comprising an external diameter of about 3 French to about 8 French.
13. A multi-angulated catheter comprising, in order:
(a) a coiled end;
(b) a first straight portion having a first straight portion length;
(c) a first shaft including a distal end connected to said first straight portion and a proximal end opposite said distal end, said first shaft having a first shaft length; and
(d) a second shaft connected to said first shaft on said proximal end,
wherein said multi-angulated catheter is flexible so as to afford being straightened when it is advanced over a guide wire, said multi-angulated catheter returning to a multi-angulated position after said guide wire is withdrawn, and wherein said first shaft and said first straight portion define a first obtuse angle when viewed from a direction substantially perpendicular to a plane defined by said first and second shafts, and said first straight portion extends out of plane with respect to said plane defined by said first and second shafts.
14. The multi-angulated catheter of claim 13, wherein said first straight portion extends from said plane at an angle of about 5° to about 140°.
15. The multi-angulated catheter of claim 13 or claim 14, wherein said first straight portion length is about 15 mm to about 40 mm.
16. The multi-angulated catheter of any one of claims 13-15, wherein said first shaft length is about 20 mm to about 40 mm.
17. The multi-angulated catheter of any one of claims 13-16, wherein said first obtuse angle is about 105° to about 140°.
18. The multi-angulated catheter of any one of claims 13-17, wherein said first shaft and said second shaft define a second obtuse angle, one of said first and second obtuse angles being a positive angle and the other being a negative angle.
19. The multi-angulated catheter of claim 18, wherein said second obtuse angle is about 135° to about 150°.
20. The multi-angulated catheter of any one of claims 13-19, wherein said proximal end is positioned from said coiled end at a distance of about 30 mm to about 60 mm.
21. The multi-angulated catheter of any one of claims 13-20, wherein said second shaft has a second shaft length, and said second shaft length is greater than said first shaft length.
22. The multi-angulated catheter of any one of claims 13-21, wherein said first straight portion length, said first shaft length, and said first obtuse angle are so dimensioned as to facilitate accessing a left ventricle from an arm of a patient.
23. The multi-angulated catheter of any one of claims 13-22, wherein said coiled end comprises an open aperture in a tip of said coiled end.
24. The multi-angulated catheter of any one of claims 13-23, wherein said coiled end comprises one or more apertures in a sidewall of said coiled end.
25. The multi-angulated catheter of any one of claims 13-24, wherein said coiled end comprises a pigtail loop.
26. The multi-angulated catheter of any one of claims 13-25, comprising an external diameter of about 3 French to about 8 French.
27. A method for radial ventriculography comprising:
inserting a guide wire into an arm of a patient;
inserting said multi-angulated catheter of any one of claims 1-26 over said guide wire into said arm;
advancing said multi-angulated catheter over said guide wire through an artery into said patient's heart, said multi-angulated catheter being flexible so as to afford being straightened when it is advanced over said guide wire;
withdrawing said guide wire, whereupon said multi-angulated catheter returns to a multi-angulated position;
advancing said multi-angulated catheter in said multi-angulated position into a left ventricle of said patient;
injecting a radiopaque dye into said left ventricle; and
making a visual representation of said left ventricle.
28. The method of claim 27, wherein said multi-angulated catheter is inserted into a small radial artery in a wrist of said patient, into an ulnar artery in a wrist of said patient, or into a brachial artery in an elbow of said patient.
29. The method of claim 27 or claim 28, wherein said multi-angulated catheter is advanced through an axillary artery of said patient.
30. The method of any one of claims 27-29, wherein said multi-angulated catheter is advanced through a subclavian artery of said patient.
31. The method of any one of claims 27-30, wherein said multi-angulated catheter is advanced through an innominate artery of said patient.
32. The method of any one of claims 27-31, wherein said arm of said patient is a right arm of said patient.
EP13840954.5A 2012-09-25 2013-09-24 Multi-angulated catheter Active EP2900310B1 (en)

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US201261705183P 2012-09-25 2012-09-25
US13/722,511 US10463781B2 (en) 2011-12-20 2012-12-20 Multi-angulated catheter
PCT/US2013/061301 WO2014052266A1 (en) 2012-09-25 2013-09-24 Multi-angulated catheter

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EP2900310A1 true EP2900310A1 (en) 2015-08-05
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EP2900310B1 EP2900310B1 (en) 2020-06-03

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Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4747840A (en) * 1986-09-17 1988-05-31 Ladika Joseph E Selective pulmonary arteriograph catheter
DE4140904A1 (en) 1991-12-12 1993-06-17 Philips Patentverwaltung TRANSMISSION DEVICE
DE9215779U1 (en) * 1992-11-20 1993-02-04 Dammenhayn, Lutz, Dr.med., 3160 Lehrte Special catheter for coronary angiography
US6036682A (en) * 1997-12-02 2000-03-14 Scimed Life Systems, Inc. Catheter having a plurality of integral radiopaque bands
US6066126A (en) * 1997-12-18 2000-05-23 Medtronic, Inc. Precurved, dual curve cardiac introducer sheath
US6285903B1 (en) * 1998-06-30 2001-09-04 Eclipse Surgical Technologies, Inc. Intracorporeal device with radiopaque marker
US6926669B1 (en) * 2000-10-10 2005-08-09 Medtronic, Inc. Heart wall ablation/mapping catheter and method
US20030114832A1 (en) * 2001-12-14 2003-06-19 Kohler Robert Edward Interventional catheter with three dimensional articulation
US20050203425A1 (en) * 2004-03-10 2005-09-15 Phil Langston Coaxial dual lumen pigtail catheter
US20090082756A1 (en) * 2007-09-25 2009-03-26 Vasundhara Vidyarthi Transradial coronary catheter

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